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NCT06315738 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis
A Phase 1 study of Necrotizing Enterocolitis, sponsored by Noveome Biotherapeutics, formerly Stemnion.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 7
- Study locations
NCT06315738: Recruiting Phase 1 study of Necrotizing Enterocolitis, sponsored by Noveome Biotherapeutics, formerly Stemnion.
NCT06315738 is a Phase 1 study of Necrotizing Enterocolitis that is actively recruiting participants, run by Noveome Biotherapeutics, formerly Stemnion. The registered enrollment target is 36 participants, below the 311-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (88% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06315738, a Phase 1 study of Necrotizing Enterocolitis, is actively recruiting participants, sponsored by Noveome Biotherapeutics, formerly Stemnion.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 7
- Study locations
Study Summary
The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL/kg and 1.0 mL/kg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC.
Primary Outcome
Patients will be assessed for safety and tolerability of ST266 treatment given IV (two dose options: 0.5mL/kg or 1.0mL/kg) via review of treatment emergent adverse events (TEAEs). AEs are defined as per the International Neonatal Consortium (INC) neonatal AE severity scale (NAESS): Mild, Moderate, Severe, Life Threatening, Death. Relatedness to study drug (ST266) will also be assessed.
Conditions Studied
Interventions
- BIOLOGICAL ST266
Study Locations (7)
Florida
- Orlando Health, Inc. Winnie Palmer Hospital for Women and Babies - Orlando
- BayCare Health System-St. Joseph's Women's Hospital - Tampa
Connecticut
- Yale-New Haven Hospital - New Haven
Illinois
- NorthShore University-Evanston Hospital - Evanston
North Carolina
- Duke University Medical Center (DUMC) - Durham
Oklahoma
- Oklahoma Children's Hospital - Oklahoma City
Pennsylvania
- University of Pittsburgh Medical Center Magee Womens Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2029-11 |
| Phase | Phase 1 |
What NCT06315738 shows while recruiting
NCT06315738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 311-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Necrotizing Enterocolitis appearing as the primary indexed condition, and to 1 intervention - of which ST266 is the first listed.
NCT06315738 lists 7 locations in 6 states (Florida, Connecticut, Illinois).
Frequently Asked Questions
What is clinical trial NCT06315738 about?
NCT06315738 is a clinical study titled "Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis". The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (...
What is the current status of trial NCT06315738?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2024-08-19. Estimated completion is 2029-11.
What conditions does trial NCT06315738 study?
This clinical trial studies the following conditions: Necrotizing Enterocolitis.
What interventions are being tested in trial NCT06315738?
The interventions under investigation include: ST266 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06315738?
This trial is sponsored by Noveome Biotherapeutics, formerly Stemnion, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06315738 being conducted?
This trial has 7 study locations across Connecticut, Florida, Illinois, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06315738's enrollment target sits among peer trials
36 14th of 14 higher than 1 of 14 other Necrotizing Enterocolitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Necrotizing Enterocolitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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